{"schema_version":"secwatch.filing_event.v1","accession":"0001398733-26-000003","form_type":"8-K","ticker":"AQST","cik":"0001398733","company_name":"Aquestive Therapeutics, Inc.","filed_at":"2026-01-09T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.986995+00:00","generated_at":"2026-05-16T11:02:37.087479+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA identifies deficiencies in Aquestive's Anaphylm NDA, precluding labeling talks","bullets":["FDA letter notes deficiencies in Anaphylm NDA that preclude labeling and post-marketing discussions; review ongoing with PDUFA date Jan 31, 2026.","Company working to understand and resolve deficiencies; delay in potential approval possible if concerns not resolved by PDUFA date.","Unaudited cash and equivalents of ~$120M as of Dec 31, 2025; company believes it is sufficient for U.S. launch and global expansion.","Global strategy advancing: expects to submit in Canada H1 2026, Europe H2 2026, and feedback from UK MHRA in Q1 2026.","Anaphylm supported by 11 clinical studies with ~967 administrations; PK profile comparable to epinephrine auto-injectors."],"urls":{"canonical":"https://secwatch.observer/filing/0001398733-26-000003","json":"https://secwatch.observer/filing/0001398733-26-000003.json","markdown":"https://secwatch.observer/filing/0001398733-26-000003.md","text":"https://secwatch.observer/filing/0001398733-26-000003.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1398733/000139873326000003/0001398733-26-000003-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1398733/000139873326000003/aqst-20260109.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:02:37.087479+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}